Patent Application
20080009903
The present invention is a high strength surgical suture material with surgically-useful qualities, including knot tie down characteristics and handling.
For purposes of simplicity and clarity, the term “PEEK,” as used herein, is to be understood as including all variants of ether and ketone, including but not limited to, polyetherketone (PEK), polyetherketoneketone (PEKK), polyetherether-ketone (PEEK), and other ether and ketone variants.
The term “enhancement fiber,” as used herein, is to be understood as including polyester, silk, nylon, ultrahigh molecular weight polyethylene and aramid, and combinations thereof.
The term “yarn(s),” as used herein, is to be understood as including fiber(s), filament(s), and the like. Typically, yarns are comprised of fibers and/or filaments.
The PEEK component of the present invention provides strength, and the enhancement fiber is provided to improve tie ability and tie down characteristics.
Referring now to the drawings, where like elements are designated by like reference numerals,
In accordance with the present invention, optional colored traces 12 are preferably black. The black trace assists surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace. Traces also assist the surgeon in identifying whether or not, and in what direction, the suture is moving. The trace can extend the entire length of the suture or only on half of a length of suture, the other half of the suture length remaining plain (white). Alternatively, the traces can form visibly distinct coding patterns on each half of the suture length. As a result, when the suture is threaded through the eyelet of a suture anchor, for example, the two legs (halves) of the length of suture are easily distinguished, and their direction of travel will be readily evident when the suture is pulled during surgery. Other patterns and arrangements of tracings also can be provided.
Ultrahigh molecular weight polyethylene yarns 8 are substantially translucent or colorless. All or the majority of the PEEK yarns 10 are white (undyed). Optionally, one or more PEEK or nylon yarns 12 may be provided in a contrasting color provide a trace in the suture. Due to the transparent nature of the ultrahigh molecular weight polyethylene, the suture takes on the color of yarns 10 and 12, and thus appears to be white with a trace in the contrasting color. In accordance with the present invention, trace yarns 12 are preferably provided in black. The black trace assists the surgeon in differentiating between suture strands with the trace and suture strands without the trace. The trace also assists the surgeon in identifying whether the suture is moving.
The colored yarns preferably are dyed. Natural fibers, such as silk, and some synthetic fibers, accept dye more readily than others. Other synthetic fibers can be colored during manufacture by tinting the polymeric material from which they are formed. In a further aspect of the invention, colored traces can be produced by exposing the braided suture material to a dye that is accepted by some materials and rejected by others. Those yarns that accept the dye become the colored trace, while yarns that reject the dye remain their original color, such as translucent or white.
In one embodiment, half of a length of suture is provided with tinted tracing yarns, or otherwise contrasts visually with the other half of the length of suture, which remains a plain, solid color, or displays a different tracing pattern, for example. Accordingly, when the length of suture is loaded through the eyelet of a suture anchor or passed through tissue, for example, at least one of the legs of the suture is visually coded, making identification and handling of the suture legs simpler. Easy identification of suture in situ is advantageous in surgical procedures, particularly during arthroscopic surgeries and others, such as endoscopy and laparoscopy, that currently are generally referred to as “minimally invasive.”
Details of the present invention will be described further below in connection with the following examples:
Core: 3 twisted yarns of ultrahigh molecular weight polyethylene (144 decitex each)
Jacket: 8 yarns PEEK (100 or 94 decitex) braided with 8 yarns ultrahigh molecular weight polyethylene (144 decitex)
The suture includes a multifilament jacket formed of ultrahigh molecular weight polyethylene yarn braided with PEEK. The jacket surrounds a yarn core substantially or entirely of ultrahigh molecular weight polyethylene.
The jacket is formed using eight yarns of 100 or 94 decitex PEEK braided with eight yarns of 144 decitex ultrahigh molecular weight polyethylene. The core is formed of three twisted yarns of 144 decitex ultrahigh molecular weight polyethylene, twisted at about three to six twists per inch.
Core: 1 yarn of ultrahigh molecular weight polyethylene (144 decitex)
Jacket: 8 twisted yarns PEEK (each yarn made of 2 twisted yarns of 45 decitex) braided with 8 yarns ultrahigh molecular weight polyethylene (144 decitex)
The jacket is formed using eight twisted yarns of PEEK braided, each yarn comprised of two twisted yarns of 45 decitex each, with eight yarns of 144 decitex ultrahigh molecular weight polyethylene. The core is formed of a yarn of 144 decitex ultrahigh molecular weight polyethylene.
Core: 3 yarns of PEEK (100 decitex each)
Jacket: 8 twisted yarns PEEK (94 or 100 decitex) braided with 8 yarns ultrahigh molecular weight polyethylene (144 decitex)
The jacket is formed using eight yarns of 94 or 100 decitex PEEK braided with eight yarns of 144 decitex ultrahigh molecular weight polyethylene. The core is formed of three twisted yarns of 100 decitex PEEK.
Core: 3 twisted yarns of ultrahigh molecular weight polyethylene (144 decitex each)
Jacket: 8 twisted yarns PEEK (90 decitex) braided with 8 yarns ultrahigh molecular weight polyethylene (144 decitex)
The core is formed using three twisted yarns of 144 decitex ultrahigh molecular weight polyethylene, twisted at about three to six twists per inch. The jacket is formed using eight yarns of 144 decitex ultrahigh molecular weight polyethylene, braided with eight twisted yarns of PEEK.
Core: 3 twisted yarns of ultrahigh molecular weight polyethylene (144 decitex each)
Jacket: 16 yarns PEEK (94 or 100 decitex)
The jacket is formed using sixteen yarns of 94 or 100 decitex PEEK. The core is formed of three twisted yarns of 144 decitex ultrahigh molecular weight polyethylene.
Core: 3 twisted yarns of PEEK (100 decitex each)
Jacket: 16 yarns PEEK (94 or 100 decitex)
The jacket is formed using sixteen yarns of 94 or 100 decitex PEEK. The core is formed of three twisted yarns of 100 decitex PEEK.
Made on a 16 carrier Hobourns machine, the yarns used in the hollow, plain braided jacket are PEEK, polyester type 712, and nylon. The jacket is formed using eight (8) yarns of PEEK per carrier, braided with six (6) yarns of 190 decitex polyester, and two (2) yarns of tinted nylon. The core is formed of three (3) carriers of PEEK or ultrahigh molecular weight polyethylene braided at three (3) to six (6) twists per inch. A No. 5 suture is produced.
Core: 1 end of 100 decitex PEEK×3 ply
Jacket: 5 carriers 95 decitex polyester; 6 carriers 100 decitex PEEK; 1 carrier 84 decitex silk
The jacket is formed using six yarns of 100 decitex PEEK, braided with five yarns of 95 decitex polyester, and one strand of 84 decitex silk. The core is formed of three twisted yarns of 100 decitex PEEK or 144 decitex ultrahigh molecular weight polyethylene.
Core: 1 end of 100 decitex PEEK×3 ply
Jacket: 7 carriers 95 decitex polyester; 8 carriers 100 decitex PEEK; 1 carrier 84 decitex silk
The jacket is formed using eight yarns of 100 decitex PEEK, braided with seven yarns of 95 decitex polyester, and one yarn strand of 84 decitex silk. The core is formed of three twisted yarns of 100 decitex PEEK or 144 decitex ultrahigh molecular weight polyethylene.
Core: 3 yarns of ultrahigh molecular weight polyethylene (144 decitex)
Jacket: 8 yarns of 144 decitex ultrahigh molecular weight polyethylene; 8 yarns of PEEK (94 or 100 decitex)
The core is formed using three yarns of 144 decitex ultrahigh molecular weight polyethylene, twisted at about three to six twists per inch. The jacket is formed using eight yarns of 144 decitex ultrahigh molecular weight polyethylene, braided with eight yarns of 94 or 100 decitex PEEK with thirty yarns.
As stated previously, one or more yarns in the blend of any of the above examples can be provided in pre-dyed colors, e.g., black, to provide a trace. The trace threads enhance the ability to visually detect suture motion and the ability to differentiate between colored and uncolored suture strands.
To make various sizes of the inventive suture, different decitex values and different PPI settings can be used to achieve the required size and strength needed. In addition, smaller sizes may require manufacture on 12, 8 or 6 carrier machines, for example. The very smallest sizes can be made without a core. Overall, the suture may range from 5% to 90% PEEK (preferably at least 31% of the yarns are PEEK), with the balance formed of enhancement fibers, such as polyester and/or silk. The core preferably comprises 12.6% or greater of the total amount of yarn.
The suture preferably is coated with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid 202A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the braid, knot security, or abrasion resistance, for example.
According to an alternative embodiment of the present invention, a partially bioabsorbable suture is provided by blending PEEK yarns with a bioabsorbable material, such as PLLA or one of the other polylactides, for example. A suture made with about 10% PEEK blended with absorbable yarns would provide greater strength than existing bioabsorbable suture, and with less stretch. Over time, 90% or more of the suture would absorb, leaving only a very small remnant of the knot. The absorbable suture can include coatings and tinted traces as noted above for nonabsorbable suture.
In one method of using the suture of the present invention, the suture 2 is attached to a suture anchor 14 as shown in
In yet another embodiment, as shown in
In yet another embodiment, the half-and-half lengths of suture can be threaded through the eyelet of a suture anchor 40, as shown in
Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred, therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.
This application claims priority to U.S. Provisional Application No. 60/819,001, filed on Jul. 7, 2006, and U.S. Provisional Application No. 60/915,296, filed on May 1, 2007, the entire disclosures of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60819001 | Jul 2006 | US | |
| 60915296 | May 2007 | US |
